- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05426681
Spinal Cord Injury Neuroprotection With Glyburide (SCING)
Spinal Cord Injury Neuroprotection With Glyburide (SCING): Pilot Study: An Open-Label Prospective Evaluation of the Feasibility, Safety, Pharmacokinetics, and Preliminary Efficacy of Oral Glyburide (DiaBeta) in Patients With Acute Traumatic Spinal Cord Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: H. Francis Farhadi, MD, PhD
- Phone Number: 859-323-5661
- Email: francis.farhadi@uky.edu
Study Contact Backup
- Name: Jaimie L Hixson, BS
- Phone Number: 8593231908
- Email: jlhend3@uky.edu
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- Recruiting
- University of Kentucky
-
Contact:
- Francis Farhadi, MD, PhD
- Phone Number: 859-562-0247
- Email: francis.farhadi@uky.edu
-
Contact:
- Jaimie Hixson, BS
- Phone Number: 859-323-4585
- Email: jlhend3@uky.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- No life threatening injuries resulting from the traumatic accident
- No evidence of sepsis
- Acute cervical or thoracic SCI with ASIA Impairment Scale Grade A, B, or C od admission.
- Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12
Exclusion Criteria:
- Unconsciousness or other mental impairment that prevents neurological assessment within the first 8 hours
- Acute SCI with ASIA Impairment Scale grade D or E
- Currently involved in another non-observational SCI research study or receiving another investigational drug
- History of hypersensitivity to sulfonylureas, in particular glyburide, or any of its components
- Any condition likely to result in the patient's death within the next 12 months
- Severe renal disorder from the patient's history (e.g. dialysis) or baseline eGFR of < 30 mL/min/1.73 m2
- Known severe liver disease, or ALT > 3 times upper limit of normal or bilirubin
- Blood glucose <55 mg/dL at enrollment or immediately prior to administration of DiaBeta, or a clinically significant history of hypoglycemia
- Acute ST elevation myocardial infarction, and/or acute decompensated heart failure, and/or QTc > 520 ms, and/or known history of cardiac arrest (PEA, VT, VF, asystole), and/or admission for an acute coronary syndrome, myocardial infarction, or coronary intervention (percutaneous coronary intervention or coronary artery surgery) within the past 3 months
- Known G6PD enzyme deficiency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glyburide treatment arm
|
Enrolled patients will receive 12 doses of Glyburide starting within 8 hours of spinal cord injury. The dosing regimen involves an initial dose of 1.25mg followed by 11 consecutive doses of 0.625 mg every 6 hours. The total daily dose of Glyburide on Day 1, Day 2, and Day 3 will be 3.125 mg, 2.5 mg, and 2.5 mg respectively. Intervention: Drug: Glyburide
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of recruitment of patients with tSCI within the specified time window.
Time Frame: within 8 hours of tSCI
|
A measure of feasibility of undertaking a large phase II study among this population of patients where treatment must begin within a short injury-to-drug time window.
|
within 8 hours of tSCI
|
Number of drug related adverse events.
Time Frame: One year post treatment
|
A measure of safety of treating patients with traumatic spinal cord injury with Glyburide administered orally.
|
One year post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurologic recovery following tSCI
Time Frame: One year post enrollment.
|
Neurologic status be assessed using the American Spinal Injury Association Impairment Scale. This neurological exam assesses sensory and motor impairments using touch and pin prick evaluations in each dermatome and muscle strength. Right and left body sides are evaluated independently. Lower the scores indicate greater degree of impairment. Touch and pin prick perception is scored using a 0-2 and NT grade. Where 0= Absent, 1= hypo/hypersensitivity, 2= normal sensation, and NT= not testable. Scores for each body side are added together and summed for a total sensation score. Maximum score possible for this section is 112 per side. Muscle function is rated on a 0-5 scale. Where 0= total paralysis, 1= palpable/visible contraction, 2= active movement, full ROM with gravity eliminated, 3= active movement, full ROM against gravity, 4= active movement, full ROM with moderate resistance, 5= Normal movement and strength, and NT= not tested. Maximum score for this section is 50 per side. |
One year post enrollment.
|
Serum Pharmacokinetics to measure Glyburide concentrations.
Time Frame: Enrollment through post-treatment day 7.
|
Plasma concentrations of Glyburide will be serially quantified through day 3 following tSCI to evaluate the pharmacokinetics of the investigational drug.
Comparisons will be made to reported levels achieved in healthy patient cohorts.
|
Enrollment through post-treatment day 7.
|
Biomarker Analysis
Time Frame: Enrollment, Day 3, and Day 7
|
Standard enzyme-linked immunosorbent assay (ELISA) techniques will be used to measure blood levels of neurofilament light chain, neuron- specific enolase, tau, S100b, and glial fibrillary acidic protein levels on admission, at 24 hours and on days 3 and 7 following tSCI to evaluate serum biomarker levels.
Comparisons will be made to previously published values observed in non-treated control patients
|
Enrollment, Day 3, and Day 7
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 77662
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Spinal Cord Injury
-
University of British ColumbiaRecruitingSpinal Cord Injuries | Acute Spinal Cord Injury | Acute Spinal Paralysis | Trauma, Spinal CordCanada
-
Jill M. Wecht, Ed.D.Icahn School of Medicine at Mount SinaiRecruitingBlood Pressure | Spinal Cord Injuries | SCI - Spinal Cord Injury | Blood Pressure Disorders | Traumatic Spinal Cord Injury | Acute Spinal Cord Injury | Neuromodulation | Spinal Cord StimulationUnited States
-
Kringle Pharma, Inc.Recruiting
-
AlaMab Therapeutics (Shanghai) Inc.RecruitingAcute Spinal Cord InjuryChina
-
University of British ColumbiaUnited States Department of DefenseRecruitingSpinal Cord Injuries | Acute Spinal Cord InjuryCanada
-
Pharmazz, Inc.Recruiting
-
Ohio State UniversityTerminated
-
Chinese Academy of SciencesThe First Affiliated Hospital of Soochow University; General Hospital of Ningxia... and other collaboratorsUnknownAcute Spinal Cord InjuryChina
-
University of CalgaryHotchkiss Brain Institute, University of Calgary; AANS/CNS Section on Disorders...TerminatedAcute Spinal Cord InjuryUnited States, Canada
-
Acorda TherapeuticsUnited States Department of Defense; DP Clinical, Inc.TerminatedAcute Spinal Cord Injury
Clinical Trials on GlyBURIDE Oral Tablet
-
EstetraICON Clinical ResearchCompletedVasomotor Symptoms | Menopausal SymptomsUnited States, Canada
-
EicOsis Human Health Inc.RecruitingHealthy SubjectsNew Zealand
-
Harmony Biosciences, LLCActive, not recruitingMyotonic Dystrophy 1 | Excessive Daytime SleepinessUnited States, Canada
-
Syntrix Biosystems, Inc.National Institute on Drug Abuse (NIDA); DF/Net ResearchCompletedDiabetic Neuropathies | Neuropathic Pain | Pain, ChronicUnited States
-
University of OxfordNovo Nordisk A/SRecruitingDiabetes Mellitus, Type 2United Kingdom
-
Fulcrum TherapeuticsTerminated
-
EicOsis Human Health Inc.CompletedHealthy AdultsUnited States
-
Cara Therapeutics, Inc.CompletedChronic Kidney Diseases | PruritusUnited States
-
Baylor Research InstituteNot yet recruitingBreast Cancer | Metastatic Triple-Negative Breast CarcinomaUnited States
-
Cara Therapeutics, Inc.RecruitingChronic Kidney Diseases | PruritusUnited States